FROM INTERVENTION DEVELOPMENT TO SERVICES: EXPLORATORY RESEARCH GRANTS (R34)

RELEASE DATE:  March 18, 2003

PA NUMBER:  PAR-03-078

March 2, 2006 (NOT-OD-06-046)   Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date. The 
non-AIDS portion of this funding opportunity expires on the date indicated below. 
A Replacement R34 (PAR-06-248) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

EXPIRATION DATE for Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for AIDS and AIDS-Related Applications: May 2, 2006 

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This Program Announcement (PA) replaces the following R21 Announcements: 
Exploratory/Development Grants for Mental Health Intervention Research
(PA-99-134), Pilot Effectiveness Trials for Mental Disorders (PAR-99-118),
and NIMH Therapeutic Effectiveness Protocol Development Program (PAR-99-119).

The purpose of this R34 is to encourage research on 1) the development and/or
pilot testing of new or adapted interventions 2) pilot testing interventions
with demonstrated efficacy in broader scale effectiveness trials, or 3)
innovative services research directions that require preliminary testing or
development.

This mechanism provides resources for evaluating the feasibility, tolerability, 
acceptability and safety of novel approaches to improving mental health and 
modifying health risk behavior, and for obtaining the preliminary data needed
as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention
or services study.  NIMH intervention and services research is aimed at
preventing or ameliorating mental disorders, emotional or behavioral problems,
the co-occurrence of mental, physical and substance abuse problems, HIV
infections, and the functional consequences of these problems across the life
span.  This PA addresses several recommendations of the National Advisory
Mental Health Council: Bridging Science and Service
(http://www.nimh.nih.gov/research/bridge.htm); Translating Behavioral Science
into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm); and Priorities for
Prevention Research at NIMH
(http://www.nimh.nih.gov/research/priorrpt/index.htm).

RESEARCH OBJECTIVES

Exploratory Development grants for MH Intervention and Services Research are 
designed to support the early phases of intervention development or adaptation, 
protocol development and preliminary pilot testing to support a full-scale
(e.g., RO1) efficacy or effectiveness study, and innovative services research.
For the purpose of intervention development or pilot testing, "intervention"
is broadly defined to include psychosocial, pharmacologic, somatic or
combination approaches to prevent disorder; efforts to treat disorder in the
acute and later phases, such as continuation and maintenance; efforts to
prevent relapse, side effects, or co-morbid symptoms and disorders;
rehabilitative efforts to reduce residual symptoms and/or enhance functioning;
efforts to target provider behavior change; or system organizational efforts
to improve care quality, coordination or delivery.  In terms of innovative
services research, pilot studies might include explorations of the use of
approaches and concepts new to a particular substantive area, research and
development of new techniques, or initial research to develop a body of data
upon which significant future research may be built (i.e., potential for
high impact).

Integrated preventive, rehabilitative, treatment and services strategies should 
consider the timing and sequencing of these strategies, as well as the
development of incremental outcome measures that could reflect cumulative
effects of multiple interventions.  Outcomes may be defined at the individual,
group, system, or population levels, or any of these in combination.

1.  Development and Pilot Testing of New or Adapted Interventions

Intervention development can be considered to have three stages:
1) conceptualizing an intervention based on theory and empirical research,
2) developing and standardizing the intervention, and 3) pilot testing.

(Stage 1) Applicants should explicate a clear conceptual link between relevant 
psychological or behavioral factors, various intervention components being
proposed (including a description of the mechanisms of action by which these
components are hypothesized to have an effect), and their relationship to the
particular aspects of outcome that are being targeted.  It is also appropriate
to present data from prior research describing characteristics of client
subgroups, settings, care providers or other relevant variables that were
associated with non-response, partial response or relapse.  New interventions
should be designed or adapted to address factors (such as participant
personality variables, expectancies or preferences, behavioral and
interpersonal skills deficits, training/supervision of care providers,
organizational characteristics, insufficient medication dosing, etc.) that
have previously been identified as predictors of positive or negative client
outcomes.  High priority will be given to applications that demonstrate the
systematic translation of basic behavioral and neurobiological processes
(e.g., cognition, memory, attention, emotion, personality) into applied
interventions.  Attention should also be given to the effects of these
interventions with underserved populations in disparate social, economic,
cultural and environmental contexts.

(Stage 2) Standardization of an intervention includes procedures such as the 
following: development of a treatment protocol (e.g., psychotherapy manual, 
medication dosing schedule, quality improvement effort) including iterations
to this protocol based on information such as feedback from patients, care
providers and other investigators; development or adaptation of relevant
measures including diagnostic, cost and outcome assessments; formulation of
measures of provider competency, acceptance and adherence to the protocol,
implementation fidelity, and participant acceptance and/or behavior change
related to the treatment.  Components of the intervention should be
operationalized in as much detail as appropriate commensurate with its
present stage of development.

(Stage 3) Pilot and feasibility studies involve testing and further refining
the intervention manual and measures developed during Stage 2.  Typically,
data are gathered to estimate intervention parameters (e.g., effect size,
attrition rates, response rates) and to perform preliminary power analyses.
In some instances pilot tests take the form of small, tightly controlled
efficacy trials designed to hold constant or eliminate any factors that could
reduce the treatment effect, including patient heterogeneity.  However, under
other circumstances an alternative design might be more appropriate depending
upon the nature of the research question, the number of participants included
in the study, the characteristics of the disorder or population being studied,
the risks and benefits of providing (or withholding) an intervention from the
target population, subject recruitment concerns (especially for rare diseases),
or the availability of other effective interventions to patients in their
communities.  Therefore, under certain circumstances, investigators might need
to consider alternative methodologies, including quasi-experimental or even
uncontrolled single case designs, if necessary.  It is the responsibility of
the investigator to provide a justification for the type of experimental
design chosen.  In summary, the goal of this phase of research is for the
investigator to propose the most rigorous means of collecting data (in light
of ethical or other limitations) that will prepare him or her to conduct a
larger, more definitive test of the intervention in the future.

For exploratory/development grants, the goals of the study should be clearly 
outlined and related to specific aims and procedures pertinent to whichever 
stage(s)of development will be pursued.  It is acknowledged that boundaries
between the stages above are non-discrete and therefore, investigators may
propose ideas or methods including subsets of one or more categories.
Importantly, however, the proposal should include a clearly operationalized
description of each component step, with decision points indicating when each 
has been successfully completed and when to move onto subsequent components.  
Furthermore, investigators are not expected to necessarily complete all phases 
of development during the 3-year duration of the award.  They should propose 
feasible and systematic goals that can be accomplished within the time and 
funding constraints of this award while considering the aim of accomplishing 
the prerequisites for conducting a larger (e.g., R01) study.

Examples of possible intervention development or adaptation studies include,
but are not limited to:

o  Development of novel interventions to target specific risk factors for 
psychopathology, co-morbid mental and other physical disorders, vulnerability 
to HIV infection, or etiologic factors identified through basic behavioral, 
epidemiological or neuroscience research

o  Adaptation of specific interventions already established as efficacious in 
one target population or domain to be applied to a different group (e.g., 
diverse cultural groups, children, older adults) or target behavior (e.g., 
adherence, HIV-risk reduction).

o  Development and/or standardization of naturally occurring helping resources 
in the community or nontraditional forms of intervention delivery.

2.  Adaptation and Pilot Testing for Effectiveness

The principal aim of effectiveness (or public health-oriented) research is to 
determine whether interventions with demonstrated efficacy under tightly 
controlled conditions can have a measurable beneficial effect when implemented 
in less precisely controlled circumstances with more heterogeneous populations, 
providers and settings.  These studies have broad inclusion and relatively few 
exclusion criteria.  Exclusion criteria are based more on concerns for 
participants' safety than on achieving tight control over extraneous sources 
of variation that may complicate causal interpretations of intervention 
effects.  Age, gender, ethnic minority status, and comorbidity are seen as 
important dimensions on which to ensure sample representativeness and 
generalizability, rather than as bases for participant exclusion.  Potential 
outcomes are broad and often include variables such as performance (school, 
work, etc.), relationship functioning (family, interpersonal, etc.), HIV risk 
reduction, disability, quality of life, mortality, institutionalization, and 
health care resource use in addition to measures of psychiatric morbidity.  
When conducting effectiveness research on an intervention with previously 
demonstrated efficacy, information regarding its initial degree of "fit"
within an applied setting (e.g., specialty or primary care, school or work 
site) and the iterative process that is expected to occur when altering the 
intervention for successful implementation within this setting should be 
articulated.

Examples of possible research questions include, but are not limited to:

o  Studies to broaden understanding of an existing preventive or treatment 
intervention strategy (e.g., dosage, duration, care delivery system fit, 
prevention setting)

o  Feasibility studies to gather estimates of parameters necessary for the 
conduct of larger scale effectiveness trials (e.g., effect sizes, population 
variance)

o  Standardization of research instruments, database construction and protocol 
development for conducting full-scale effectiveness studies

o  Studies to develop and standardize provider training protocols, supervisory 
standards, or implementation of fidelity procedures 

3.  Innovative Services Research

This program announcement is also intended to encourage applications to 
facilitate innovative services research directions that require preliminary 
testing or development.  Such pilot studies might include service delivery 
model development, explorations of the use of approaches and concepts new to
a particular substantive area, research and development of new techniques, or 
initial research to develop a body of data upon which significant future 
research may be built (i.e., potential for high impact).  Studies designed to 
develop and/or test novel service delivery models should reflect one or more 
of the 3 stages of intervention development described in the "Development and 
Pilot Testing of New or Adapted Interventions" section of this Program 
Announcement.  Additional examples of relevant services research areas might 
include "practice research," studies of dissemination/implementation and/or 
organizational processes, and/or the analysis of complex, multi-dimensional 
mental health care delivery systems.  Research in these areas may require 
novel or mixed methodologies and/or innovative statistical approaches.  
Consequently, examples of research applications in this area include but are 
not limited to:

o  Studies to develop novel service delivery models (e.g., aftercare services, 
rehabilitation, social setting, school or community-based, online/virtual 
communities) designed to target children, adolescents, adult or geriatric 
individuals with complex, comorbid and/or chronic conditions

o  Studies to develop organizational or systemic interventions to ease 
administrative burdens, reduce provider turnover or burnout, increase consumer 
satisfaction or service engagement

o  Pilot studies to understand "real world" care delivery system 
characteristics that might facilitate or impede the integration of novel or 
adapted intervention techniques (e.g., reimbursing physicians for HIV risk 
reduction counseling during routine visits).

o  Preliminary studies of new methodological approaches for the analysis of 
complex and dynamic systems

o  Studies to design or validate instruments to measure dissemination or 
implementation processes, changes in consumer functioning, or organizational 
environments

MECHANISM(S) OF SUPPORT

This PA will use the NIH R34 award mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  Under this program announcement, applicants for the R34 award may 
request direct costs of up to $450,000 for three years.  For those 
applications that include a subcontractual/consortium arrangement, facilities 
and administrative (F&A) costs on those consortium arrangements would be 
included in the direct costs.  While variations from year to year are 
permissible, in no case may any year be more than 225,000 in direct costs, and 
total direct costs for the entire project period may not exceed $450,000.  
Grant applications may request 1, 2, or three years of support.  This award 
is non-renewable.  However, it is intended that grantees funded through this 
exploratory phase program will elect to seek continuing support for their 
projects through the R01 grant mechanism.

This PA uses just-in-time concepts.  It also uses modular budgeting format.  
Given that these applications will have direct costs in each year of $250,000 
or less, the modular budgeting format should be used in all applications. 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  This program 
does not require cost sharing as defined in the current NIH Grants Policy 
Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the following 
characteristics:

o  For-profit or non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Units of State and local governments
o  Eligible agencies of the Federal government
o  Domestic or foreign
o  Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

Any research project which involves a Phase I or Phase II Clinical Trial must 
include a Data and Safety Monitoring Plan.  See the Federal Citations section, 
below, for further information and references.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o  Direct your questions about scientific/research issues to:

Linda Street, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892-9635
Telephone:  (301) 443-0651
FAX:  (301) 594-6784
Email:  Lstreet@nih.gov

Dianne Rausch, Ph.D.
Deputy Director, Center for Mental Health Research on AIDS 
National Institute of Mental Health
6001 Executive Boulevard, Room 6212
Rockville, MD  20852
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  dr89b@nih.gov

Regina T. Dolan-Sewell, Ph.D.
Division of Mental Disorders, Behavioral Research & Aids
National Institute of Mental Health
6001 Executive Boulevard, Room 6183, MSC 9625
Bethesda, MD  20892-9625
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  rdolan@mail.nih.gov

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD  20892-9608
Rockville, MD  20852-9608 (for express/courier service)
Telephone:  (301) 443-1340
FAX:  (301) 443-4720
Email:  kozakm@mail.nih.gov

o  Direct your questions about financial or grants management matters to:

Joy R. Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  jk173@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which are 
available at http://grants.nih.gov/grants/dates.htm.  Application deadlines are 
also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.  
The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction addressing 
the previous critique.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  An appropriate scientific review group convened in 
accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.

As part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o  Receive a second level review by the National Advisory Mental Health Council

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following aspects 
of your application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals: 

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that drive 
this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?  

(3) INNOVATION:  Does your project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does your project challenge existing 
paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR:  Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

o  In line with a major purpose of this PA, namely to evaluate the feasibility, 
tolerability, acceptability and safety of novel approaches to improving mental 
health, and for obtaining the preliminary data needed as a pre-requisite to a 
larger-scale (efficacy or effectiveness) intervention or services study:  How 
likely is it that the proposed research will generate data that will lead to a 
firm conclusion about the feasibility of a regular research project grant or 
full scale clinical trial?  Is information provided about the scope and goals 
of intended future work?

o  For applications intending to develop or adapt a new treatment or service 
for a new population, setting or system, is there a clear conceptual link 
between the nature of the psychopathology, the treatment components proposed, 
and their relationship to the outcome variables being targeted?  Is empirical 
evidence available which demonstrates the need to adapt an existing 
intervention or service e.g., because in its current form it has failed to 
achieve a complete and lasting remission among all patients in all settings 
that have received it?  Does the application describe how the new adaptation 
will enhance responding for subgroups of patients that previously experienced 
partial remission, relapse or dropped out from the existing therapy?

o  For applications intending to develop or adapt a new treatment or service, 
is there an adequate description of which stage of intervention development 
best characterizes the application and is a clear rationale provided for the 
choice of methods proposed?  For stage 3 applications, investigators are not 
limited to use of between group designs for pilot studies.  In the absence of 
a controlled design, do such applications describe the use of other, innovative 
(e.g., single case, quasi experimental or uncontrolled) designs that best take 
into account the ethical and methodological considerations that arise when 
using small sample sizes (e.g., the statistical concerns that arise when 
comparing 2 active treatments, the risks of withholding treatment from 
seriously ill patients, the availability of alternative effective treatments 
in the community, etc.)?  Does the application adequately consider these issues 
in choosing the most appropriate research design and providing a clear 
explanation for their decision?  Whenever possible, are mechanisms of action, 
that are hypothesized to have an effect on patient outcome, articulated?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

ADDITIONAL CONSIDERATIONS 

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds
o  Relevance to program priorities

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and others, 
and the importance of the knowledge gained or to be gained.

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for assessment 
of patient eligibility and status, rigorous data management, quality assurance, 
and auditing procedures.  In addition, it is NIH policy that all clinical 
trials require data and safety monitoring, with the method and degree of 
monitoring being commensurate with the risks (NIH Policy for Data and Safety 
Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at http://grants.nih.gov/grants/funding/women_min/guidelines
_amended_10_2001.htm.  The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language governing 
NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 
and updated roles and responsibilities of NIH staff and the extramural 
community.  The policy continues to require for all NIH-defined Phase III 
clinical trials that: a) all applications or proposals and/or protocols must 
provide a description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including subgroups if 
applicable; and b) investigators must report annual accrual and progress in 
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them.  This policy applies to all initial (Type 1) applications submitted 
for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a project 
that is supported in whole or in part with Federal funds and (2) cited publicly 
and officially by a Federal agency in support of an action that has the force 
and effect of law (i.e., a regulation) may be accessed through FOIA.  It is 
important for applicants to understand the basic scope of this amendment.  
NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a description 
of the archiving plan in the study design and include information about this in 
the budget justification section of the application.  In addition, applicants 
should think about how to structure informed consent statements and other human 
subjects procedures given the potential for wider use of data collected under 
this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving 
the health promotion and disease prevention objectives of "Healthy People 
2010," a PHS-led national activity for setting priority areas.  This PA is 
related to one or more of the priority areas.  Potential applicants may obtain 
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

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			Department of Health and Human Services (HHS)
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